WC500169468

Table of contents
1. Introduction .......................................................................................... 10
1.1. Welcome and declarations of interest of members, alternates and experts ................. 10
1.2. Adoption of agenda for the meeting on 5-8 May 2014 ............................................. 10
1.3. Minutes of the previous PRAC meeting on 7-10 April 2014 ....................................... 10
2. EU Referral Procedures for Safety Reasons: Urgent EU Procedures ....... 10
2.1. Newly triggered procedures ................................................................................. 10
2.1.1. Ivabradine - PROCORALAN (CAP), CORLENTOR (CAP) .......................................... 10
2.2. Ongoing Procedures ............................................................................................ 11
2.2.1. Methadone medicinal products for oral use containing povidone (NAP) ................... 11
2.3. Procedures for finalisation ................................................................................... 12
3. EU Referral Procedures for Safety Reasons: Other EU Referral Procedures
.................................................................................................................. 12
3.1. Newly triggered Procedures ................................................................................. 12
3.1.1. Hydroxyzine (NAP) .......................................................................................... 12
3.2. Ongoing Procedures ............................................................................................ 13
3.2.1. Ambroxol (NAP); bromhexine (NAP) .................................................................. 13
3.2.2. Ponatinib - ICLUSIG (CAP) ................................................................................ 13
3.2.3. Testosterone (NAP) .......................................................................................... 14
3.2.4. Valproate and related substances: sodium valproate, valproic acid, valproate
semisodium, valpromide (NAP) ................................................................................... 14
3.3. Procedures for finalisation ................................................................................... 15
3.4. Article 5(3) of Regulation (EC) No 726/2004 as amended: PRAC advice on CHMP
request .................................................................................................................... 15
4. Signals assessment and prioritisation ................................................... 15
4.1. New signals detected from EU spontaneous reporting systems ................................. 15
4.1.1. Androgen Deprivation Therapy (ADT) (NAPs) Abiraterone - ZYTIGA (CAP); degarelix -
FIRMAGON (CAP) ...................................................................................................... 15
4.1.2. Atazanavir – REYATAZ (CAP)............................................................................. 16
4.1.3. Quetiapine (NAP) ............................................................................................. 17
4.1.4. Temozolomide – TEMODAL (CAP) ...................................................................... 17
4.2. New signals detected from other sources ............................................................... 18
4.2.1. Bisphosphonates (CAP, NAP): alendronate (NAP), risedronate (NAP); alendronate,
colcalciferol – ADROVANCE (CAP), FOSAVANCE (CAP), VANTAVO (CAP); strontium ranelate –
OSSEOR (CAP), PROTELOS (CAP) ............................................................................... 18
4.2.2. Ivabradine – CORLENTOR (CAP), PROCORALAN (CAP) .......................................... 19
4.2.3. Valproic acid (NAP) .......................................................................................... 20
4.3. Signals follow-up and prioritisation ....................................................................... 21
4.3.1. Azithromycin (NAP) .......................................................................................... 21
4.3.2. Fentanyl, transdermal patch (NAP) .................................................................... 22
4.3.3. Fluticasone furoate - AVAMYS (CAP) .................................................................. 23
4.3.4. Leuprorelin, suspension for injection (NAP) ......................................................... 24
4.3.5. Paracetamol (NAP)........................................................................................... 25
4.3.6. Sitagliptin – JANUVIA (CAP), RISTABEN (CAP), TESAVEL (CAP), XELEVIA (CAP);
Sitagliptin, metformin – EFFICIB (CAP), JANUMET (CAP), RISTFOR (CAP), VELMETIA (CAP);
Angiotensin-converting enzyme (ACE) inhibitors (NAP) .................................................. 26
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 4/73